MICOMITIN ANTIFUNGAL- tolnaftate liquid 
PureTek Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Micomitin™
Antifungal Liquid
Tolnaftate 1%

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use on

children under 2 years of age unless directed by a doctor.

When using this product

  • do not get into eyes

Stop use and ask a doctor

  • for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
  • for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use under the direction of a medical practitioner

Other information

How Supplied

Micomitin™Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-640-03)

Inactive ingredients

Apple Cider Vinegar, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, DMSO (Dimethyl Sulfoxide), Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Laureth-4, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, DL-alpha-tocopheryl acetate.

Micomitin™
Antifungal Liquid

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

label

MICOMITIN ANTIFUNGAL 
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-640
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.3 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ARGAN OIL (UNII: 4V59G5UW9X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURETH-4 (UNII: 6HQ855798J)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-640-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/30/2023
Labeler - PureTek Corporation (785961046)

Revised: 8/2023
Document Id: de9842ba-0255-8ae1-e053-2995a90a0664
Set id: de9842ba-0254-8ae1-e053-2995a90a0664
Version: 1
Effective Time: 20230830
 
PureTek Corporation